Clinical trial · Interventional
Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer
NCT01463709CI-TRIAL-00009534NPEFcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Basal Cell Carcinomas | Basal Cell Carcinoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PulseCure pulse generator and Derm-pulse electrode | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- nanopulse
- description
- Administer nano pulse to lesion for varying time intervals.
- interventionNames
- Device: PulseCure pulse generator and Derm-pulse electrode
Primary outcomes (1)
- measure
- Demonstrate the safety of PulseCure pulse generator and NanoBlate electrode and identify the optimal pulse number for treating basal cell carcinomas.
- timeFrame
- One year
- description
- 1\. Conduct a non-significant risk feasibility clinical trial treating BCCs on the trunk of up to 9 Basal Cell Nevus Syndrome patients with BioElectroMed's PulseCure pulse generator and Derm-Pulse electrode to both demonstrate the safety of nsPEF therapy and identify the optimal pulse number for ablating BCCs.
Secondary outcomes (1)
- measure
- Determine the efficacy of the PulseCure pulse generator using the optimal pulse number.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Study subjects must have had diagnosed at least one BCCon their trunk 2. The subject is from 18-75 years of age, inclusive. 3. The subject must sign and date all informed consent statements. Exclusion Criteria: 1. The subject is exhibiting signs of a bacterial or viral infection, including fever. 2. The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis. 3. The subject has a pace maker or other electronic device implanted
References
Publications (0)
Data not yet available
No reference posted for this study.